FDA Commissioner Discusses Future of CV Medicine

Aug 08, 2016

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Advances in technology, along with an increased use of social media and personal devices, could offer new possibilities for treating patients and improving outcomes, but the new approaches must be rigorously evaluated, according to a guest editor’s page by U.S. Food and Drug Administration Commissioner Robert M. Califf, MD, MACC, published Aug. 8 in the Journal of the American College of Cardiology.

Califf writes that death from cardiovascular disease dropped 40 percent in the 2000s and new drug and technology developments will likely further improve outcomes. However, he cautions that there is a potential for harm if systems for evidence generation and health care delivery do not improve as rapidly as technology and provide the guidance needed to use new advancements appropriately. The cardiovascular community is a leader in evidence-based medicine, but only about 15 percent of major practice guidelines are supported by high-quality evidence, Califf writes. However, he notes that dramatic improvements in the rate, quantity and quality of evidence generation are within reach. Electronic health records, as well as social media combined with wearable devices are leading to new opportunities in patient- and population-level data, he explains.

Califf also discusses the FDA’s future role in nutrition and diet issues, and acknowledges that miscues, such as the broad recommendations on intake of cholesterol and carbohydrates, have undermined public confidence and created opportunities for self-styled experts to profit from dubious advice. Beyond fundamental basics, there is not a clear-cut answer on what people should eat for optimal health and quality of life, but as evidence is generated across large populations, the FDA will look forward to a new era of studies in this area that take advantage of our evolving evidence generation system.

Other areas Califf discusses are phenotyping in early-phase clinical trials, integrative biomarkers and monitoring, targeted therapy, devices, regenerative medicine, disease at the beginning and end of life, and disparities.

“The partnerships between the FDA and multiple communities of stakeholders have successfully reduced death and disability from cardiovascular disease,” Califf concludes. “Now, ingenious research and technology development, combined with general advances in biological and information technologies, will further accelerate improvement in outcomes. But if we are to harness these technologies and apply them effectively, our systems for evidence generation and health care delivery must continue to improve in concert with drugs, devices, and biological products.”